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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05761821
Other study ID # SYSKY-2023-056-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Yangxin Chen, PhD
Phone +8602081332360
Email chenyx39@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.


Description:

In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient received implantation of leadless pacemaker - Patient agreed to join into this study and signed informed consent Exclusion Criteria: - Age < 18 years - Ventricular septal defect - History of mechanical tricuspid valve replacement - History of inferior vena cava filter placement - Pregnant or plan to be pregnant within 2 years - Life expectancy < 1 year - Patient was included in other studies that could introduce bias into this study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Leadless pacemaker
All enrolled patients were implanted with leadless pacemaker.

Locations

Country Name City State
China Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serious adverse events including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection Day 0 (Time of implantation)-Day 7
Secondary Device-related complications Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury Day 0 (Time of implantation)-Day 7
Secondary Device-related complications Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous Day 0 (Time of implantation)-Year 2
Secondary Serious adverse events including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection Day 0 (Time of implantation)-Year 2
Secondary Re-intervention of devices extraction, re-implantation, or implantation of traditional transvenous pacemaker Day 0 (Time of implantation)-Year 2
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